Kornimate/medical-research-clean huggingface dataset:
resistive index measurements after kidney transplantation

Conditions: Kidney Failure

Summary: the purpose of this study is to evaluate the prognostic performance of intrarenal resistive index in the first years after kidney transplantation on graft function and on patient and graft survival. in addition, the determinants of the intrarenal resistive index, including a detailed analysis of the relation between graft histology and the intrarenal resistive index, will be assessed.

since march 2004, and as part of routine clinical practice, protocol renal allograft biopsies are routinely performed at implantation and at 3, 12 and 24 months after transplantation, in all patients who receive a kidney transplant at the university hospitals leuven, unless there is a medical contra-indication or patient refusal to undergo this procedure. the biopsies are scheduled using a dedicated microsoft access database ("biopsy database"), that is maintained on the central servers of the university hospitals leuven. patients who have an unexplained change in renal allograft function, undergo additional clinically indicated indication biopsies. these biopsies are also recorded in the aforementioned microsoft access database. all clinical data, including pretransplant donor and recipient characteristics, and post-transplant follow-up data are directly stored and maintained in a prospectively collected electronic database (ccl database until 06/2012, transferred to the central kws database in 2012). this electronic database is the only existing clinical database for these patients, and contains all clinical patient charts. no written records are collected. all renal allograft biopsies will be rescored by a single renal pathologist according to the most recent banff classification, blinded for the clinical parameters and timing of the biopsy. these rescoring data are directly entered in the dedicated microsoft access database ("biopsy database"). just prior to performing a renal allograft biopsy with ultrasound guidance, and as part of the routine clinical procedure, duplex measurements are performed by the radiologist who will perform the biopsy. the peak systolic velocity (vmax) and the minimal diastolic velocity (vmin) are determined in each patient in two to three representative interlobar arteries. the resistive index is calculated as \[1 - (v min/v max)\]. this procedure is repeated at three different places in the kidney (lower, interpolar and upper pole). these data are directly entered in the central electronic clinical database system (kws, see above). all electronic data will be transferred to a sas database at time of data extraction.

Eligibility criteria:
inclusion criteria: single kidney transplantation exclusion criteria: none
effect of preparation design on the functional and esthetic outcome of cad/cam lithium disilicate laminate veneers

Conditions: Dental Disorders Hard Tissues of Teeth; Tooth Discoloration

Summary: conservatism is considered the main concern in any treatment plan, the feather edge preparation design of laminate veneers have been introduced yet clinical studies are lacking to evaluate their clinical performance.the aim of this study is to evaluate the effect of the two different preparation designs on the functional and esthetic outcome of laminate veneers in terms of marginal adaptation, retention, fracture, marginal discoloration and patient satisfaction


Eligibility criteria:
inclusion criteria: * from 18-60 years old, and able to read and sign the informed consent document. * patients with teeth problems indicated for laminate veneers. * physically and psychologically able to tolerate conventional restorative procedures. * have no active periodontal or pulpal diseases. * maintenance of good oral hygiene . * willing to return for follow-up examinations and evaluation. exclusion criteria: * patients in the growth stage with partially erupted teeth. * patients with para-functional habits. * cases that need modification in the incisal edge. * patients with poor oral hygiene and motivation . * psychiatric problems or unrealistic expectations.

Keywords: laminates vertical preparation veneers
hemodynamic stability in septic shock patients undergoing continuous renal replacement therapy with oxiris membrane

Conditions: Acute Kidney Injury Due to Sepsis

Summary: the new adsorbing membrane for continuous renal replacement therapy (crrt), oxiris, can reduce plasma cytokines and endotoxins in septic shock patients with severe acute kidney injury, compared with standard membranes. however, its hemodynamic stability or benefits have not been thoroughly evaluated although this is reasonable.

the new adsorbing membrane for continuous renal replacement therapy (crrt), oxiris, can reduce plasma cytokines and endotoxins in patients with severe acute kidney injury or sepsis, compared with standard membranes. based on this benefit, the use of oxiris may confer better outcomes than other membranes. the patient outcomes include cardiovascular, respiratory, renal, and overall survivals, but this information of oxiris are insufficient. although cytokine and endotoxin removal rates are great in oxiris, the beneficial effects on the hard outcomes are needed to use oxiris in real clinical practice. the inflammatory and cardiovascular systems have intensive crosstalk, and thus if there are remission in inflammatory process, the patients can have hemodynamic stability. regarding this, the investigators would like to compare the hemodynamic stability between oxiris and other standard membrane such as polysulfone, using our new real-time monitoring registry.

Eligibility criteria:
inclusion criteria: * aged ≥ 18 years * sepsis related acute kidney injury requiring continuous renal replacement therapy exclusion criteria: • no monitoring of blood pressure and ecg
calcium-phosphorus regulation therapy on heart valve disease

Conditions: Degenerative Heart Valve Disease; Heart Valve Calcification; Chronic Kidney Disease(CKD); Calcium-Phosphorus Metabolism Disorders

Summary: the goal of this clinical trial is to learn if calcium-phosphorus regulation therapy can slow the progression of heart valve calcification in patients with degenerative heart valve disease and chronic kidney disease (ckd). the main questions it aims to answer are: * does sevelamer lower the progression of heart valve calcification compared to calcium carbonate over 12 months? * what are the impacts of calcium-phosphorus regulation therapy on major cardiovascular events such as heart failure, cardiovascular death, and the need for valve surgery? researchers will compare sevelamer to calcium carbonate to see if sevelamer is more effective in reducing heart valve calcification. participants will: * take sevelamer or calcium carbonate daily for 12 months. * undergo echocardiography and ct scans at baseline and after 12 months to assess heart valve calcification. * attend follow-up visits at 3, 6, 9, and 12 months to monitor blood tests and adjust treatment as needed.


Eligibility criteria:
inclusion criteria: * age ≥ 50 years old. * degenerative valvular heart disease clearly diagnosed by ultrasound or clinical history with calcification manifestation (including no stenosis or insufficiency due to calcification, mild, moderate and severe stenosis and insufficiency caused by calcification). * glomerular filtration rate \< 60 ml/min (ckd-epi formula). * serum phosphorus \> 1.45 mmol/l (4.5 mg/dl). exclusion criteria: * patients refuse to sign the informed consent form for the study. * non-degenerative valvular heart disease even if there is valvular calcification, such as rheumatic valvular heart disease, congenital valvular heart disease, etc. * valve lesions are evaluated by cardiac surgeons and have indications for surgical thoracotomy or interventional medical treatment and there are no surgical contraindications. * life expectancy less than 1 year. ⑤ abnormal parathyroid function. * those with renal insufficiency who are planned to undergo dialysis treatment within half a year. * malignant tumor.

Keywords: heart valve calcification degenerative valve disease chronic kidney disease calcium-phosphorus regulation sevelamer
ascending dose study of genome editing by the zinc finger nuclease (zfn) therapeutic sb-913 in subjects with mps ii

Conditions: Mucopolysaccharidosis II; MPS II

Summary: the purpose of the study is to evaluate the safety, tolerability and effect on leukocyte and plasma iduronate 2-sulfatase (ids) enzyme activity of ascending doses of sb-913. sb-913 is an intravenously delivered zinc finger nuclease (zfn) therapeutic for genome editing. it inserts a correct copy of the ids gene into the albumin locus in hepatocytes with the goal of lifelong therapeutic production of the ids enzyme.

the objectives of the study are to provide long term expression of ids and improve the current clinical outcome of enzyme replacement therapy (ert) in subjects with mps ii, a recessive lysosomal storage disorder that results from mutations in the gene encoding ids. sb-913 is a therapeutic for zfn-mediated genome editing which will be delivered by adeno-associated virus (aav)-derived vectors. sb-913 is intended to function by placement of the corrective copy of ids transgene into the genome of the subject's own hepatocytes, under the control of the highly expressed endogenous albumin locus, and is expected to provide permanent, liver-specific expression of iduronate 2-sulfatase for the lifetime of an mps ii patient.

Eligibility criteria:
inclusion criteria: * male or female 5 years to 65 years of age. * clinical diagnosis of mps ii (based on evidence of hepatosplenomegaly, dysostosis multiplex by x-ray, valvular heart disease, or obstructive airway disease) ids deficiency confirmed by gene sequencing. exclusion criteria: * known to be unresponsive to ert * neutralizing antibodies to aav 2/6 * serious intercurrent illness or clinically significant organic disease (unless secondary to mps ii) * receiving antiviral therapy for hepatitis b or c, or with active hepatitis b or hepatitis c or hiv 1/2 * lack of tolerance to idursulfase treatment with significant iars or occurrence of anaphylaxis * markers of hepatic dysfunction * creatinine ≥ 1.5 mg/dl * contraindication to the use of corticosteroids for immunosuppression * current treatment with systemic (iv or oral) immunomodulatory agent or steroid use (topical treatment allowed) * participation in prior investigational drug or medical device study within the previous 3 months * prior treatment with a gene therapy product * elevated or abnormal circulating α-fetoprotein (afp) * weight \< 20 kg at screening visit

Keywords: mps ll mucopolysaccharidosis ii hunter syndrome gene editing gene therapy zinc finger zfn sb-913 rare genetic dna sangamo genome editing champions hunter gene specific targeted insertion
a study to evaluate safety and efficacy of iv sildenafil in the treatment of neonates with persistent pulmonary hypertension of the newborn

Conditions: Pulmonary Hypertension, Familial Persistent, of the Newborn

Summary: this study will evaluate whether iv sildenafil can reduce the time on inhaled nitric oxide treatment and reduce the failure rate of available treatments for persistent pulmonary hypertension of the newborn.


Eligibility criteria:
inclusion criteria: * neonates with persistent pulmonary hypertension of the newborn * age \ =34 weeks gestational age * oxygenation index \>15 and \<60 * concurrent treatment with inhaled nitric oxide and \>=50% oxygen exclusion criteria: * prior or immediate need for extracorporeal membrane oxygenation or cardiopulmonary resuscitation * expected duration of mechanical ventilation \<48 hours * profound hypoxemia * life-threatening or lethal congenital anomaly

Keywords: persistent pulmonary hypertension newborn neonates iv sildenafil hypoxic respiratory failure and at risk of persistent pulmonary hypertension of the newborn
the dystonia coalition natural history and biospecimen repository for isolated dystonias

Conditions: Dystonia

Summary: dystonia is a disorder characterized by excessive involuntary contraction of muscles with repetitive and patterned movements. the isolated dystonias are the most common type of dystonia and include limb dystonias (like writer's cramp), cervical dystonia (spasmodic torticollis), laryngeal dystonias (like spasmodic dysphonia), and craniofacial dystonias (like blepharospasm). the purpose of this study is to create resources to help learn more about the isolated dystonias, myoclonus dystonia, and dopa-responsive dystonia and to develop and validate various dystonia rating scales.

this collaborative, international effort has one primary goal. this is to create a biospecimen repository and associated clinical database to be used as a resource for dystonia and related disease research. across sites, the investigators hope to enroll at least 5,000 adult patients. subjects of this study will be asked to complete a neurological exam which will be video recorded, complete some questionnaires, and donate a blood sample. a study visit will take between 45 minutes and 1 hour. all subjects will be asked to return every 1, 2, 3, or 4 years for a one hour follow-up visit. people may participate in this study without agreeing to participate in the follow-up visits.

Eligibility criteria:
inclusion criteria: * diagnosed with isolated dystonia or myoclonus dystonia or dopa-responsive dystonia * to be included in laryngeal dystonia group, nasolaryngoscopy (voice box exam) must have been completed to confirm diagnosis (this voice box exam is not part of the study) exclusion criteria: * any evidence of a secondary cause for dystonia (other than myoclonus dystonia or dopa-responsive dystonia) * less than 2 months since last botulinum toxin injection * inability to provide informed consent * significant medical or neurological conditions that preclude completing the neurological exam * significant physical or other condition that would confound diagnosis or evaluation, other than dystonia or tremor

Keywords: observational study cross-sectional and prospective study cohort and case-control study
high-dose methotrexate in treating young patients with residual ependymoma

Conditions: Brain and Central Nervous System Tumors

Summary: rationale: drugs used in chemotherapy, such as methotrexate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. purpose: this phase ii trial is studying how well high-dose methotrexate works in treating young patients with residual ependymoma.

objectives: primary * determine the activity of high-dose methotrexate as upfront-window therapy in young patients with residual ependymoma. secondary * assess the reasons why primary surgery was complete/incomplete in these patients. * assess the feasibility and toxicity of second-look surgery after 3 courses of high-dose methotrexate in cases where initial surgery was incomplete. outline: this is a multicenter, open-label study. patients receive high-dose methotrexate iv continuously over 24 hours on days 0, 14, and 28 in the absence of disease progression or unacceptable toxicity. patients then proceed to further chemotherapy on protocol ukccsg-cns-9204. after completion of study treatment, patients are followed periodically for 9 years. projected accrual: a total of 29 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed ependymoma, including the following histologic variants: * cellular * papillary * clear-cell * tanycytic * anaplastic (malignant) ependymoma * the following diagnoses are excluded: * myxopapillary ependymoma * subependymomas * ependymoblastomas * primitive neuroectodermal tumors (pnets) * other neuroepithelial tumors * choroid plexus tumors * germ cell tumors * residual measurable ependymoma after maximal surgical resection, including second-look surgery, if deemed necessary * has undergone surgical resection within the past 3 weeks patient characteristics: * at least 3 months to under 3 years of age * neutrophil count \> 1,000/mm\^3 * platelet count \> 100,000/mm\^3 * able to tolerate chemotherapy * no co-existent unrelated disease (i.e., renal or hematological) that would preclude chemotherapy treatment prior concurrent therapy: * see disease characteristics * recovered from prior surgery * no previous chemotherapy * previous steroids allowed * no previous radiotherapy

Keywords: childhood infratentorial ependymoma childhood supratentorial ependymoma newly diagnosed childhood ependymoma
pharmacokinetics of anti-tuberculosis drugs in gastrectomized patients

Conditions: Tuberculosis; Tuberculosis, Pulmonary; Early Gastric Cancer

Summary: the purpose of this study is to evaluate the effect of gastrectomy on pharmacokinetic profile of first-line anti-tuberculosis drugs in patients with pulmonary tuberculosis (tb).

gastrectomy is a well-known risk factor for tb. also, there were some reports about malabsorption of anti-tb drugs in the gastrectomized patients. however, pharmacokinetics of recently used first line anti-tb drugs in the gastrectomized patients have not been well evaluated simultaneously. therefore, the investigators aim to evaluate the effect of gastrectomy on pharmacokinetic profile of first-line anti-tb drugs in patients with pulmonary tb through this study.

Eligibility criteria:
inclusion criteria: 1. age greater than 18 years and less than 80 years 2. pulmonary tb confirmed by microbiologic test such as afb culture or tb pcr 3. usage of 4 first-line anti-tb drugs (isoniazid(inh) rifampin(rfp) ethambutol(emb), pyrazinamide(pza) = hrez) exclusion criteria: 1. patients with liver disease (bilirubin ≥ 1.5 mg/d or ast ≥ 2 x normal upper limit) or chronic renal failure (cr ≥ 2.0 mg/d) who cannot use first-line anti-tb drugs 2. patients with aids or hypoalbuminemia(albumin \< 3.0g/dl)that will influence pharmacokinetics of first line anti-tb drugs 3. patients using other drugs that will influence pharmacokinetics of first line anti-tb drugs during anti-tb treatment (e.g warfarin) 4. patients using anti-cancer or immunosuppressive agents that will influence the response of pulmonary tb to anti-tb drugs 5. discontinuation of first-line anti-tb drugs(hrez)due to side effect or resistance 6. follow-up loss before completion of anti-tb treatment 7. any condition making the patients undergo gastrectomy during anti-tb treatment in case of non-gastrectomy group

Keywords: tuberculosis pharmacokinetics first-line drugs gastrectomy
haiti rural school feeding study: effect of vita mamba on anemia and hemoglobin concentrations

Conditions: Malnutrition

Summary: this study applied a matched cluster, controlled design, using community cluster as the unit of randomization. communities were first matched during the formative research phase and randomized into treatment (vita mamba + deworming) or control (deworming) groups, using a simple experimental 1:1 design. the principal investigator generated the random allocation sequence and assigned the cluster to groups. children were followed longitudinally for hb concentration and anthropometric measures were taken at baseline (november 2014) and endline (june 2015). parents were surveyed at baseline for household-level socioeconomic and demographic information; environmental conditions including water, hygiene, and sanitation; and child diet and morbidities. all children in the intervention schools received the vita mamba once per school day from november 2014 to june 2015, for approximately 26 weeks. children in both groups received albendazole at baseline in november 2014. compliance was monitored by teachers and tracked by collection of empty packages. lessons learned from another school feeding trial by the study team were applied to increase compliance such as opening the packages for the children immediately prior to consumption to discourage selling or sharing later with family members. vita mamba was developed for the urban school trial by the research team with representatives from edesia (a us-based nonprofit manufacturer of ready-to-use foods with expertise in research and development) and nutriset (the parent company in the plumpyfield network). meds \& food for kids, a nonprofit manufacturer of ready-to-use foods in haiti using locally produced peanuts, produced the vita mamba for this trial. vita mamba (50 g) contains 260 kcal and meets \>75% of the recommended dietary allowance (rda) for critical micronutrients (s1 table).


Eligibility criteria:
inclusion criteria: * registration in the study school for 2014-2015 calendar; good health (no fever, congenital health condition, or peanut or soy allergy); and not severely malnourished (weight-for-height \[whz\] \<-3) exclusion criteria: * fever, congenital health condition, or peanut or soy allergy; severely malnourished (weight-for-height \[whz\] \<-3)
application of mechanical cardiopulmonary resuscitation devices and their value in out-of-hospital cardiac arrest: a retrospective analysis of the german resuscitation registry

Conditions: Out-of-hospital Cardiac Arrest

Summary: the aim of this study was to analyse a large cpr database, the german resuscitation registry, to evaluate potential benefits of mechanical cpr devices over manual cpr in adult cardiac arrest victims. the primary endpoint considered is rosc.

in a retrospective analysis of the german resuscitation registry between 2007-2014, investigators examined the outcome after using mechanical cpr on return of spontaneous circulation (rosc) in adults with out-of-hospital cardiac arrest (ohca). investigators compared mechanical cpr (intervention group) to manual cpr (control group). according to preclinical risk factors, investigators calculated the predicted rosc-after-cardiac-arrest (raca) score for each group, and compared it to the rate of rosc observed. using multivariate analysis, investigators adjusted the influence of the devices' application on rosc for epidemiological factors and therapeutic measures.

Eligibility criteria:
inclusion criteria: * out of hospital cardiac arrest * during time prod from january 2007 until december 2014 * cpr attempted exclusion criteria: * investigators excluded cases in which cpr was continued for less than five minutes, or duration of cpr was missing, as the outcome in this early period is not affected by the cpr mode. * children aged less than 18 years and patients of unknown age were also excluded as the devices are not approved for resuscitation on children. * an active compression-decompression (acd) is a hand-held suction device, to compress and actively decompress the chest after each compression. * investigators also excluded cases where acd cpr was used, because it constitutes a different technology. * cases due to trauma were excluded as application of mechanical cpr devices may be limited due in traumatic events. * cases where data on rosc and/or cpr mode was missing were also excluded.

Keywords: german resuscitation registry out-of-hospital cardiac arrest cardiopulmonary resuscitation mechanical chest compression devices
simultaneous phototherapeutic keratectomy and corneal collagen crosslinking in eyes with keratoconus: a randomized trial (shark)

Conditions: Keratoconus

Summary: the goal of this clinical trial is to compare cxl with combined treatment with cxl and t-ptk. the main questions it aims to answer are whether combined treatment can give better visual acuity and if the treatments are equally safe.


Eligibility criteria:
inclusion criteria: * patients must be 18 years or older at the time of signing the informed consent form. there is no upper age limit. * progressive keratoconus with indication for cxl * corneal thickness ≥ 420 μm exclusion criteria: * other eye disease causing visual impairment